Evolution® Biliary Stent System-Fully Covered

Exclusion Criteria

• •\< 18 years of age
• •Unwilling or unable to sign and date the informed consent
• •Unwilling or unable to comply with the follow-up schedule
• •Undergone or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources
• •Participating in another investigational drug or device study in which patient has not completed the follow-up phase for the primary endpoint at least 30 days prior to enrollment
• •Endoscopic procedures are contraindicated
• •Current anatomy upstream of intended stent placement compromising the flow of bile from the liver such that stent placement may not alleviate the biliary obstruction symptoms
• •Presence of a metal biliary stent
• •Presence of an esophageal or duodenal stent
• •Hypersensitivity/allergy or contraindication to any component of the stent, delivery system, or medication required to complete the procedure,which in the investigator's opinion cannot be adequately premedicated
• •Coagulopathy
• •Diffuse intrahepatic metastases that involves \> 10 % of the liver
• •Life expectancy of \< 3 months
• •Pregnant
• •Active alcohol or substance abuse issue
• •Jaundice secondary to a cause other than biliary duct obstruction
• •Additional endoscopic restrictions as specified in the Clinical Investigation Plan